[Federal Register Volume 61, Number 77 (Friday, April 19, 1996)]
[Notices]
[Pages 17305-17307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9674]



-----------------------------------------------------------------------

[[Page 17306]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0069]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Extension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995, 
Federal agencies are required to publish a notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on requirements relating to the approval of 
investigational new drug applications and subsequent reporting and 
recordkeeping requirements.

DATES: Submit written comments on the collection of information by June 
18, 1996.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide 60-day notice in the Federal Register concerning 
each proposed collection of information, including each proposed 
extension of an existing collection of information. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information listed below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.


Investigational New Drug (IND) Regulations (21 CFR 312) (OMB Control 
Number 0910-0014--Extension)

    FDA has the responsibility under the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 355 (i)) to issue regulations under 
which the clinical investigation of the safety and effectiveness of 
unapproved new drugs can be conducted. The IND information requirements 
are needed to ensure the safe and ethical investigation of the safety 
and effectiveness of new drugs.
    FDA is charged with implementing statutory requirements that drug 
products marketed in the United States be shown to be safe and 
effective and be properly manufactured and properly labeled for their 
intended uses. The act provides in 21 U.S.C. 355(a) that a new drug may 
not be introduced or delivered for introduction into interstate 
commerce in the United States unless FDA has previously approved a new 
drug application (NDA). FDA approves an NDA only if the sponsor of the 
application first demonstrates that the drug is safe and effective for 
the conditions prescribed, recommended, or suggested in the product's 
labeling. Proof must consist, in part, of adequate and well-controlled 
studies, including studies in humans, that are conducted by qualified 
experts.
    The IND regulations establish reporting requirements that include 
an initial application as well as amendments to that application, 
reports on significant revisions of clinical investigation plans, and 
information on a drug's safety or effectiveness. In addition, the 
sponsor is required to give FDA an annual summary of the previous 
year's clinical experience. Submissions are reviewed by medical 
officers and other agency scientific reviewers assigned responsibility 
for overseeing the specific study.
    The IND regulations also contain recordkeeping requirements that 
pertain to the responsibilities of sponsors and investigators. The 
detail and complexity of these requirements is dictated by the 
scientific procedures and human subject safeguards which must be 
followed in the clinical tests of IND's. FDA estimates the burden of 
the information collection provisions of the IND regulations as 
follows:




[[Page 17307]]



                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                        Estimated Annual Reporting Burden                                       
-----------------------------------------------------------------------------------------------------------------
                                               Annual                                                           
    21 CFR Section           No. of        Frequency per      Total Annual        Hours per        Total Hours  
                          Respondents         Response         Responses          Response                      
----------------------------------------------------------------------------------------------------------------
312.7................          7                1                  7          24 hours               168        
312.10...............          ?                ?                  ?                 ?                 ?        
312.23...............      1,623                1              1,623          100 hours          162,300        
312.30...............      1,201                9             10,809          84 hours           907,956        
312.31...............        880                5.64           4,963           8 hours            39,704        
312.32...............        440                8              3,520          20 hours            70,400        
312.33...............      1,517                2.6            3,944          450 hours         1,774,800       
312.35...............          5                1                  5          260 hours            1,300        
312.36...............        300                1                300           5 hours             1,500        
312.38...............        579                1.2              695          45 minutes             521        
312.44...............          ?                ?                  ?                 ?                 ?        
312.45...............        205                1.4              287           5 hours             1,435        
312.47...............          ?                ?                  ?                 ?                 ?        
312.55...............          ?                ?                  ?                 ?                 ?        
312.56...............        560                2.4            1,344          84 hours           112,896        
312.58...............        260                2.6              676          84 hours            56,784        
312.64...............          ?                ?                  ?                 ?                 ?        
312.66...............          ?                ?                  ?                 ?                 ?        
312.83...............          5                1                  5          160 hours              800        
312.85...............        260                2.6              676          960 hours          648,960        
312.110..............         30               11.6              348          24 hours             8,352        
312.120(b)...........        560                2.4            1,344          100 hours          134,000        
312.120(c)(3)........        560                2.4            1,344           3 hours             4,032        
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection. Where question   
  marks appear in the burden estimate, FDA does not have current information available. Public comments will be 
  greatly appreciated.                                                                                          


                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                      Estimated Annual Recordkeeping Burden                                     
-----------------------------------------------------------------------------------------------------------------
                           No. of         Annual Frequency    Total Annual        Hours per                     
   21 CFR Section       Recordkeepers     of Recordkeeping       Records        Recordkeeper       Total Hours  
----------------------------------------------------------------------------------------------------------------
312.52.............        280                  1                280          30 minutes             140        
312.53.............      4,000                  1              4,000          84 hours           336,000        
312.57.............        560                  2.4            1,344          100 hours          134,400        
312.59.............        250                  2.4              600           8 hours             4,800        
312.62(a)..........      4,000                  1              4,000          40 hours           160,000        
312.62(b)..........      4,000                 10             40,000          40 hours          1,600,000       
312.160(a).........        250                 40             10,000          30 minutes           5,000        
312.160(c).........        250                 30              7,500          30 minutes           3,750        
Total Burden Hours.                                                                             6,170,398       
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection.                  



    Dated: April 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-9674 Filed 4-18-96; 8:45 am]
BILLING CODE 4160-01-F